Fecal Microbiota Transplant(FMT) Combination With Tislelizumab in Advanced or Metastatic NSCLC

NCT07432984 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-12-108
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for non-small cell lung cancer (NSCLC) patients whose disease has progressed after immune checkpoint inhibitor (ICI) therapy, and to establish the foundation for personalized FMT through gut microbiome analysis. Recovering immune responses in patients who have failed prior immunotherapy remains an unmet clinical need. This study aims to provide evidence to address this issue. Fecal microbiota transplantation (FMT) is a means that can rapidly and efficiently change the intestinal microbiota and has the potential to affect the systemic immune environment. Therefore, this study intends to contribute to the development of future treatment strategies by evaluating whether FMT can restore the immune response and clinical efficacy in patients with immune checkpoint inhibitor-resistant NSCLC.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety(SAE, AE)

  to evaluate the clinical safety (by NCI-CTCAE v5.0)

  From enrollment to the EOT, up to 42 months

Secondary Outcomes (5)

• ORR

  up to 42 months

• OS

  up to 42 months

• PFS

  up to 42 months

• DCR

  up to 42 months

• DOR

  up to 42 months

Study Arms (1)

Fecal Microbiota Transplant(FMT) combination with Tislelizumab

EXPERIMENTAL

A fixed dose of 200mg Q3W Tislelizumab IV until PD And Q9W FMT (max 3)

Drug: Tislelizumab; Procedure: Fecal Microbiota Transplant(FMT)

Interventions

Tislelizumab DRUG

Tislelizumab 200mg IV q3wks

Also known as: Tevimbra

Fecal Microbiota Transplant(FMT) combination with Tislelizumab

Fecal Microbiota Transplant(FMT) PROCEDURE

FMT through colonoscopy q9wks up to 3 cycles.

Fecal Microbiota Transplant(FMT) combination with Tislelizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DONOR
• ① Subjects who have voluntarily provided written Informed consent to participate in this clinical trial
• ② Aged of 19 or older
• ③ Subjects who meet one of the following criteria:
• Patients with histologically confirmed NSCLC who have maintained a clinical benefit(partial response, PR) for more than 1 year through immune checkpoint inhibitor therapy
• Healthy volunteers with no history of inflammatory bowel disease ④ Subjects who agree to provide repetitive blood and fecal samples during the trial period
• RECIPIENT
• Have voluntarily provided written Informed consent to participate in this clinical trial
• Adults aged 19 years or older
• Histologically or cytologically confirmed progressive or metastatic NSCLC
• Subjects with at least one measurable lesion according to RECIST v1.1
• Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.)
• ECOG 0-1
• Subjects with a life expectancy is at least 3 months ⑧ Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:
• Absolute neutrophil count (ANC): ≥ 1.5×109/L

You may not qualify if:

• DONOR
• Have voluntarily provided written Informed consent to participate in this clinical trial
• Adults aged 19 years or older
• Histologically or cytologically confirmed progressive or metastatic NSCLC
• Subjects with at least one measurable lesion according to RECIST v1.1
• Subjects who have received one or more chemotherapy treatments and have experienced disease progression after prior immunotherapy (However, patients with confirmed EGFR or ALK mutations must have shown progression after approved targeted therapies.) ⑥ ECOG 0-1
• Subjects with a life expectancy is at least 3 months
• Subjects with adequate bone marrow and organ function within 14 days prior to study treatment, defined as:
• Absolute neutrophil count (ANC): ≥ 1.5×109/L
• Hemoglobin: ≥ 9.0 g/dL
• Platelet count: ≥ 75×109/L
• Serum creatinine ≤ 1.5×ULN or CrCl ≥ 30 mL/min as determined by Cockcroft-Gault
• AST(SGOT)/ALT(SGPT): ≤ 3×ULN (≤ 5×ULN in the presence of liver metastases)
• Total bilirubin: ≤ 1.5×ULN (\< 3×ULN for Gilbert's syndrome(unconjugated hyperbilirubinemia) or liver metastases)
• Female Subjects must be using a highly effective method of contraception during the clinical trial and for 4months after permanent discontinuation of the study drug

Sponsors & Collaborators

• Se-Hoon Lee: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Sehoon Lee, Ph.MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sehoon Lee, Ph.MD

CONTACT

+82-2-3410-3459; sehoon.lee119@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 25, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share